Medgenics, Inc., the developer of a novel technology for the sustained production and delivery of therapeutic proteins in patients using their own tissue, today announced that it has filed for Orphan Drug Designation with the U.S. Food and Drug Administration (FDA) for INFRADURE for the treatment of hepatitis D.

SynCardia Systems, Inc., manufacturer of the world's first and only FDA, Health Canada and CE (Europe) approved Total Artificial Heart, announced today that the U.S. Food and Drug Administration has approved a Humanitarian Use Device (HUD) designation for the SynCardia temporary Total Artificial Heart to be used for destination therapy ...

EpiCept Corporation announced today that AmiKet (amitriptyline 4%, ketamine 2% cream) has been granted Fast Track designation by the U.S. Food and Drug Administration.

Lexicon Pharmaceuticals, Inc., announced today that the U.S. Food and Drug Administration (FDA) has granted its request for Orphan Drug designation for telotristat etiprate (LX1032) for the treatment of carcinoid syndrome.

DBV Technologies announced today that it has received "Fast Track Designation" for the Clinical Development Program of its Viaskin Peanut, a product designed for the treatment by Epicutaneous Immunotherapy (EPIT) of patients with peanut allergy.

Arno Therapeutics, Inc. announced today that its investigational compound, AR-42, has been granted orphan-drug designation by the U.S. Food and Drug Administration for the treatment of meningioma and schwannoma of the central nervous system.

EpiCept Corporation today announced that it has filed for Fast Track designation for AmiKet(amitriptyline 4%, ketamine 2% cream) for the treatment for chemotherapy-induced peripheral neuropathy (CIPN) with the U.S. Food and Drug Administration.

Ceptaris Therapeutics, Inc., a privately held specialty pharmaceutical company, announced today that the European Medicines Agency (EMA) has granted Orphan Drug Designation to Ceptaris' investigational drug, chlormethine gel, for the treatment of Cutaneous T-Cell Lymphoma.

Amsterdam Molecular Therapeutics, a leader in the field of human gene therapy, announced today that the U.S. Food and Drug Administration has granted orphan drug designation to its gene therapy program for the treatment of hemophilia B.

Eric Miller, professor of electrical and computer engineering in the School of Engineering at Tufts University, has been elected a fellow by the Institute for Electrical and Electronics Engineers.

Celladon Corp., a biopharmaceutical company focused on the discovery and development of innovative treatments for cardiovascular diseases, announced that its investigational product candidate MYDICAR® has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of advanced heart failure. The Fast Track program of ...

Onyx Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Standard Review designation to the New Drug Application (NDA) for carfilzomib for the potential treatment of patients with relapsed and refractory multiple myeloma.